Attack your advanced nonsquamous NSCLC in two different ways with ALIMTA and platinum chemotherapy plus KEYTRUDA.

When these therapies were combined in a clinical study, people lived longer than those who received ALIMTA plus platinum chemotherapy. ALIMTA with carboplatin or cisplatin is a combination of chemotherapies used to treat advanced nonsquamous non-small cell lung cancer (NSCLC) cells that are dividing quickly in your body. By adding an immunotherapy called KEYTRUDA® (pembrolizumab) to this combination, your body’s own immune system is also used to attack cancer cells. Using these two types of treatment together may help you fight your lung cancer in a more effective way than ALIMTA plus platinum chemotherapy.

ALIMTA and platinum chemotherapy plus KEYTRUDA has the potential to attack healthy cells too, which can become serious and could lead to death.

Talk to your doctor to find out if ALIMTA and platinum chemotherapy plus KEYTRUDA may be an option for you, no matter what your PD-L1 test results may be.

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ALIMTA and platinum chemotherapy plus KEYTRUDA helped more people live longer than ALIMTA plus platinum chemotherapy.

In a clinical study, an estimated 7 out of 10 people were alive at 1 year in the ALIMTA and platinum chemotherapy plus KEYTRUDA group compared to an estimated 5 out of 10 people in the ALIMTA plus platinum chemotherapy group.

Chart showing that, in KEYNOTE-189, 7 out of 10 people were estimated to be alive at 1 year in the ALIMTA and platinum chemotherapy plus KEYTRUDA group vs 5 out of 10 people in the ALIMTA plus platinum chemotherapy group.

In a clinical study, people treated with ALIMTA and platinum chemotherapy plus KEYTRUDA lived nearly 9 months without their cancer spreading or getting worse compared to almost 5 months with ALIMTA plus platinum chemotherapy.

Cancer did not progress in 40% of people receiving ALIMTA and platinum chemotherapy plus KEYTRUDA compared with 19% of people receiving ALIMTA and platinum chemotherapy.

Cancer did not progress in 40% of people receiving ALIMTA and platinum chemotherapy plus KEYTRUDA compared with 19% of people receiving ALIMTA and platinum chemotherapy.

An estimated 34% of people were alive at 1 year without their cancer spreading or getting worse in the ALIMTA and platinum chemotherapy plus KEYTRUDA group compared to an estimated 17% of people in the ALIMTA plus platinum chemotherapy group.

Chart showing that 34% of patients in KEYNOTE-189 in KEYNOTE-189 treated with ALIMTA and platinum chemotherapy plus KEYTRUDA were estimated to be alive at 1 year without their cancer spreading or getting worse vs 17% with ALIMTA plus platinum chemotherapy.

More than twice as many people had their tumors shrink with ALIMTA and platinum chemotherapy plus KEYTRUDA compared to ALIMTA plus platinum chemotherapy.

In a clinical study, 48% of people experienced a reduction in tumor size with ALIMTA and platinum chemotherapy plus KEYTRUDA compared to 19% with ALIMTA plus platinum chemotherapy.

Chart showing 48% of people treated with ALIMTA and platinum chemotherapy plus KEYTRUDA had their tumors shrink vs 19% of people who were treated with ALIMTA plus platinum chemotherapy

The most common side effects of ALIMTA and platinum chemotherapy plus KEYTRUDA

In a clinical study, the most common side effects of ALIMTA and platinum chemotherapy plus KEYTRUDA were tiredness/weakness, nausea, constipation, diarrhea, loss of appetite, rash, vomiting, cough, shortness of breath, and fever.

In a clinical study, 23.0% of people who were treated with ALIMTA and platinum chemotherapy plus KEYTRUDA stopped taking ALIMTA because of side effects compared to 11.4% of people who were treated with ALIMTA plus platinum chemotherapy.

Indications and Important Safety Information

What Is ALIMTA® (pemetrexed for injection) Approved For?

ALIMTA® (pemetrexed for injection) is approved by the FDA in combination with KEYTRUDA® (pembrolizumab) (an immunotherapy) and platinum chemotherapy (carboplatin or cisplatin, two other chemotherapy drugs) as the first treatment for nonsquamous non-small cell lung cancer (NSCLC) that has spread with no abnormal EGFR or ALK gene.*

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the first (initial) treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC that has spread.

ALIMTA is approved by the FDA as a single agent (used alone) for maintenance treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after you have received 4 cycles of chemotherapy that contains platinum for first treatment and your cancer has not progressed.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with recurrent, metastatic nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, which has returned or spread after prior chemotherapy.

ALIMTA is not appropriate for people who have a different type of NSCLC called squamous cell.

*Epidermal growth factor receptor (EGFR) is a tumor marker found in some people with nonsquamous NSCLC. It is found on both normal and tumor cells and is important for cell growth. Anaplastic lymphoma kinase (ALK) is a protein that may be involved in cell growth. Changes to the ALK gene have been found in some types of cancer, including nonsquamous NSCLC.

Important Safety Information for ALIMTA

What is the most important information that I should know about ALIMTA?

ALIMTA can cause serious side effects including:

Low blood cell counts. Low blood cell counts can be severe, including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and low red blood cell counts (anemia). Your healthcare provider will do a blood test to check your blood cell counts regularly during your treatment with ALIMTA. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with ALIMTA.

Kidney problems, including kidney failure. ALIMTA can cause severe kidney problems that can lead to death. Severe vomiting or diarrhea can lead to loss of fluids (dehydration) which may cause kidney problems to become worse. Tell your healthcare provider right away if you have a decrease in amount of urine.

Severe skin reactions. Severe skin reactions that may lead to death can happen with ALIMTA. Tell your healthcare provider right away if you develop blisters, skin sores, skin peeling, or painful sores, or ulcers in your mouth, nose, throat or genital area.

Lung problems (pneumonitis). ALIMTA can cause serious lung problems that can lead to death. Tell your healthcare provider right away if you get any new or worsening symptoms of shortness of breath, cough, or fever.

Radiation recall. Radiation recall is a skin reaction that can happen in people who have received radiation treatment in the past and are treated with ALIMTA. Tell your healthcare provider if you get swelling, blistering, or a rash that looks like a sunburn in an area that was previously treated with radiation.

Who should not take ALIMTA?

ALIMTA may not be appropriate for some patients. If you are allergic to pemetrexed, tell your doctor because you should not receive it. It is not known if ALIMTA is safe and effective in children.

What should I tell my healthcare provider before receiving ALIMTA?

Before receiving ALIMTA, tell your healthcare provider about all of your medical conditions including:

  • if you have kidney problems.
  • if you have had radiation therapy.
  • if you think you are pregnant, or are planning to become pregnant as ALIMTA can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 6 months after the final dose. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIMTA.
    • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIMTA and for 3 months after the final dose.
  • if you are breastfeeding or plan to breastfeed, as it is not known if ALIMTA passes into breast milk. Do not breastfeed during treatment with ALIMTA and for 1 week after the final dose.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you have kidney problems and take a medicine that contains ibuprofen. You should avoid taking ibuprofen for 2 days before, the day of, and 2 days after receiving treatment with ALIMTA.

How is ALIMTA given?

It is very important to take folic acid by mouth and receive vitamin B12 injections from your healthcare provider during your treatment with ALIMTA to lower your risk of harmful side effects.

Your healthcare provider will prescribe a medicine called a corticosteroid for you to take 2 times a day for 3 days, beginning the day before each treatment with ALIMTA.

ALIMTA is given to you by intravenous (IV) infusion (injection) into your vein. The infusion is given over 10 minutes. You will usually receive ALIMTA once every 21 days (3 weeks).

What are the possible side effects of ALIMTA?

The most common side effects of ALIMTA when given alone are:

  • Tiredness
  • Nausea
  • Loss of appetite

The most common side effects of ALIMTA when given with cisplatin are:

  • Vomiting
  • Swelling or sores in your mouth or sore throat
  • Constipation
  • Low white blood cell counts (neutropenia)
  • Low platelet counts (thrombocytopenia)
  • Low red blood cell counts (anemia)

The most common side effects of ALIMTA when given with pembrolizumab and platinum chemotherapy are:

  • Tiredness/weakness
  • Nausea
  • Constipation
  • Diarrhea
  • Loss of appetite
  • Rash
  • Vomiting
  • Cough
  • Shortness of breath
  • Fever

ALIMTA may cause fertility problems in males. This may affect your ability to father a child. It is not known if these effects are reversible. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider will do blood tests to check for side effects during treatment with ALIMTA. Your healthcare provider may change your dose of ALIMTA, delay treatment, or stop treatment if you have certain side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ALIMTA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

ALIMTA is available by prescription only.

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, or call 1-800-545-5979.

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